A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
NCT ID: NCT06551324
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2024-10-21
2028-10-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)
PF-06821497
875 mg BID (2 times a day)
Enzalutamide
160 mg QD
Arm B
Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days
Docetaxel
75 mg/m2 IV (every 21 days)
Enzalutamide
160 mg QD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-06821497
875 mg BID (2 times a day)
Docetaxel
75 mg/m2 IV (every 21 days)
Enzalutamide
160 mg QD
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
* Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Exclusion Criteria
* Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:
1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
* Inadequate organ function.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urology Centers of Alabama
Homewood, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Arizona Urology Specialists (AUS)-Orange Grove
Tucson, Arizona, United States
Los Angeles Cancer Network
Anaheim, California, United States
UCSF Cancer Center Berkeley
Berkeley, California, United States
UCSF Cancer Center Burlingame
Burlingame, California, United States
Los Angeles Cancer Network
Fountain Valley, California, United States
Los Angeles Cancer Network
Glendale, California, United States
Los Angeles Cancer Network
Glendale, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
UCSF Investigational Drug Pharmacy
San Francisco, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
UCSF Cancer Center San Mateo
San Mateo, California, United States
Sutter Santa Rosa
Santa Rosa, California, United States
Stanford Health Care Attention: Investigational Pharmacy
Stanford, California, United States
Colorado Clinical Research
Lakewood, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Florida Cancer Specialists
Cape Coral, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Hospital and Clinics - Doral
Doral, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Kendall
Kendall, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
University of Miami Hospital and Clinics, UHealth Tower
Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Griffin Cancer Research Building
Miami, Florida, United States
Florida Cancer Specialists
N. Venice, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
AdventHealth Hematology and Oncology
Orlando, Florida, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Duly Health and Care
Hinsdale, Illinois, United States
Duly Health And Care
Lisle, Illinois, United States
NextStage Clinical Research-Chicago-(04)
Lisle, Illinois, United States
Duly Health and Care
Westmont, Illinois, United States
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, United States
New England Cancer Specialists
Topsham, Maine, United States
New England Cancer Specialists
Westbrook, Maine, United States
VA St. Louis Health Care System
St Louis, Missouri, United States
AtlantiCare
Egg Harbor, New Jersey, United States
Circuit Clinical /Crystal Run Healthcare LLP
Middletown, New York, United States
Circuit Clinical
Middletown, New York, United States
Crystal Run Healthcare
Monroe, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
Salisbury VA Medical Center
Salisbury, North Carolina, United States
The Centers for Advanced Urology, LLP d/b/a Keystone Urology Specialists
Lancaster, Pennsylvania, United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
USA Clinical Trials
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Harborview Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Centro de Urología (CDU)
CABA, Buenos Aires, Argentina
Hospital Sirio Libanes
Capital Federal, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Imagenes Mdq
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, Argentina
IMAXE
Buenos Aires, , Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, , Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, , Argentina
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Hospital São Carlos
Fortaleza, Ceará, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, , Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, , Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Lanzhou university second hospital
Lanzhou, Gansu, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Multiscan
Pardubice, Pardubický kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Nukleární Medicína
Hradec Králové, , Czechia
Radiodiagnostika Pardubice
Pardubice, , Czechia
Centre Antoine Lacassagne
Nice, Alpes-maritimes, France
Centre Antoine-Lacassagne
Nice, Alpes-maritimes, France
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace, France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, France
CHRU de Brest
Brest, Finistère, France
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
Nîmes, GARD, France
Oncopole Claudius Regaud
Toulouse, Haute-garonne, France
Hôpital Foch
Suresnes, Hauts-de-seine, France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, Ille-et-vilaine, France
Institut Jean Godinot
Reims, Marne, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Gustave Roussy
Villejuif, Val-de-marne, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, , France
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Urologie Neandertal - Praxis Mettmann
Mettmann, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Alexandra General Hospital of Athens
Athens, Attikí, Greece
Athens Medical Center
Athens, Attikí, Greece
Metropolitan General Hospital
Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Országos Onkológiai Intézet
Budapest, Pest County, Hungary
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
Ospedale San Raffaele
Milan, , Italy
Chiba cancer center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Keio university hospital
Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Tergooi MC
Hilversum, North Holland, Netherlands
Frisius Medisch Centrum
Leeuwarden, Provincie Friesland, Netherlands
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
MICS Centrum Medyczne Torun
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw, Lower Silesian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
Koszalin, West Pomeranian Voivodeship, Poland
Narodny onkologicky ustav
Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, , Slovakia
Univerzitna nemocnica Martin, Onkologicka ambulancia
Martin, , Slovakia
MILAB, s.r.o., Urologicka ambulancia
Prešov, , Slovakia
BEKY - MED, s.r.o.
Prešov, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
Wits Clinical Research
Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre
Pretoria, Gauteng, South Africa
TASK Eden
George, Western Cape, South Africa
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi, South Korea
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Södersjukhuset
Stockholm, Stockholms LÄN [se-01], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se-14], Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Koç Üniversitesi Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa
Istanbul, İ̇stanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi
Izmir, İ̇zmir, Turkey (Türkiye)
Adana City Hospital
Adana, , Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital
Ankara, , Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, , Turkey (Türkiye)
Royal Blackburn Hospital
Blackburn, Blackburn WITH Darwen, United Kingdom
Mid and South Essex NHS Foundation Trust
Chelmsford, Essex, United Kingdom
University College London Hospital
London, London, CITY of, United Kingdom
Western General Hospital
Edinburgh, Midlothian, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511650-50-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C2321014
Identifier Type: -
Identifier Source: org_study_id